Transbronchial needle aspiration device

ABSTRACT

Transbronchial needle aspiration (TBNA) device. In one embodiment, the device comprises a handle and a flexible catheter, the handle having a bore, the proximal end of the catheter being fixed within the handle bore. A protective tubular hub having a flared distal end is press-fit coaxially within the distal end of the catheter, the distal end of the catheter being sealed around the distal end of the hub so as to define a distal opening. A hollow needle having a sharp tip at its distal end is disposed within the catheter, the needle tip being sized for insertion through the distal opening of the catheter. The distal end of a flexible wire is coupled to the proximal end of the needle, the proximal end of the wire extending through the handle bore and coupled to a button slide accessible through a slot in the handle. The button slide is movable between a distal position in which the needle tip extends through the distal opening of the catheter and a proximal position in which the needle tip is disposed within the hub. When in either its distal position or its proximal position, a pawl on the button slide releasably engages a corresponding notch on the handle to lock the button slide in place.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of U.S. patent application Ser.No. 10/449,826, inventors Sergey S. Grigoryants et al., filed Dec. 11,2006, the disclosure of which is incorporated herein by reference.

BACKGROUND OF THE INVENTION

The present invention relates generally to tissue sampling devices andrelates more particularly to transbronchial needle aspiration devices.

In order to diagnose and to stage lung cancer in a patient, it is oftennecessary to biopsy a tissue sample from a nearby lymph node of thepatient. One type of technique that has been used in the past to obtainsuch a tissue sample involves percutaneously inserting a sampling needlethrough the patient's chest into the patient's lung and then through thebronchial wall of the lung into a nearby lymph node. Examples of devicesadapted for percutaneous tissue sampling are disclosed in the followingU.S. patents, all of which are incorporated herein by reference: U.S.Pat. No. 5,971,939, inventors DeSantis et al., which issued Oct. 26,1999; U.S. Pat. No. 5,713,368, inventor Leigh, which issued Feb. 3,1998; U.S. Pat. No. 4,799,494, inventor Wang, which issued Jan. 24,1989; and U.S. Pat. No. 4,766,907, inventors de Groot et al., whichissued Aug. 30, 1988.

Although the above-described percutaneous sampling technique has provensatisfactory in terms of time and expense, such a technique does haveits shortcomings. One such shortcoming is the risk of uncontrollablebleeding if the biopsy needle, which may be quite large in diameter,pierces or shears a blood vessel. Another shortcoming is the risk ofpneumothorax, i.e., lung collapse, resulting from the puncturing of thelung by the biopsy needle, causing air to leak from the lung and toaccumulate between the lung surface and the chest cage. In fact, ifpneumothorax is severe enough, the patient may require a chest tube todrain air from the chest cavity. Moreover, in extreme cases, thecondition may be fatal. Still another shortcoming is the risk ofinfection resulting from the percutaneous insertion of the needle intothe patient.

Accordingly, another technique that has been used to obtain a lymph nodetissue sample is transbronchial needle aspiration (sometimes referred toas “TBNA”). In transbronchial needle aspiration, the distal end of abronchoscope is inserted through a patient's mouth and to a neutrallocation within the patient's lung, the proximal end of the bronchoscopenot being inserted into the patient and, instead, extending externallythereto. The distal end of a TBNA device is then inserted through aworking channel of the bronchoscope, the proximal end of the TBNA devicenot being inserted into the bronchoscope and, instead, extendingexternally to the patient. The TBNA device typically comprises acatheter, a wire longitudinally disposed within the catheter, ahistology sampling needle coupled to the distal end of the wire, a capcoupled to the proximal end of the wire and accessible externally to thepatient for moving the wire relative to the catheter so as toalternately extend the needle beyond the distal end of the catheter andretract the needle into the catheter, and a port accessible externallyto the patient for coupling a syringe to the proximal end of thecatheter so that the syringe may provide suction to the catheter.

The TBNA device is typically loaded into a bronchoscope with its needlein a retracted position and with a syringe attached to the port. Onceconfirmation is received that the distal end of the TBNA device haspassed entirely through the bronchoscope (such confirmation typicallybeing provided using a video channel of the same bronchoscope), thebronchoscope and the TBNA device are advanced together to the targetsite, and the needle is advanced to its extended position. The needle isthen inserted through the bronchial wall of the patient and into anearby lymph node. At this time, the syringe is used to apply suction.In the unfortunate event that the needle errantly penetrates a bloodvessel, instead of a lymph node, the application of suction causes bloodto be aspirated into the catheter and the syringe, where it is detected.In such a case, the application of suction is discontinued and thebloodied TBNA device is removed from the bronchoscope and the patient. Afresh TBNA device is then loaded into the bronchoscope and the patientin the manner described above, and another attempt is made to penetratethe lymph node.

If, while suction is applied, it appears that the sampling needle haspenetrated a lymph node, as is desired, the catheter is agitated to helpshear tissue from the penetrated lymph node into the sampling needle.With a tissue sample thus disposed within the sampling needle, theneedle is retracted into the catheter. The TBNA device is then removedfrom the bronchoscope and the patient. The needle is then advanced outof the catheter, and negative suction is then used to expel the tissuefrom the sampling needle onto a slide or the like for histologicalexamination.

Examples of TBNA devices are disclosed in the following patents, all ofwhich are incorporated herein by reference: U.S. Pat. No. 5,056,529,inventor de Groot, which issued Oct. 15, 1991; U.S. Pat. No. 4,966,162,inventor Wang, which issued Oct. 30, 1990; U.S. Pat. No. 4,890,626,inventor Wang, which issued Jan. 2, 1990; U.S. Pat. No. 4,791,937,inventor Wang, which issued Dec. 20, 1988; U.S. Pat. No. 4,766,906,inventor Wang, which issued Aug. 30, 1988; U.S. Pat. No. 4,702,260,inventor Wang, which issued Oct. 27, 1987 U.S. Pat. No. 4,693,257,inventor Markham, which issued Sep. 15, 1987; U.S. Pat. No. 4,617,940,inventor Wang, which issued Oct. 21, 1986; U.S. Pat. No. 4,532,935,inventor Wang, which issued Aug. 6, 1985; and U.S. Pat. No. 4,249,541,inventor Pratt, which issued Feb. 10, 1981.

Referring now to FIGS. 1 and 2, there are shown perspective and enlargedfragmentary section views, respectively, of a conventional, commerciallyavailable embodiment of a TBNA device, said TBNA device beingrepresented generally by reference numeral 11.

Device 11 comprises a handle or body 13. Body 13 is a branched orT-shaped, tubular member shaped to include a first port 15 at itsproximal end, a second port 17 at its distal end, and a third port 19extending perpendicularly to and between said first port 15 and saidsecond port 17. Each of first port 15, second port 17 and third port 19is in fluid communication with the other two ports. Third port 19 isadapted to receive a syringe for use in providing suction to device 11.

Device 11 also comprises a flexible catheter 21. Catheter 21 has aproximal end and a distal end 23, the proximal end of catheter 21 beingfixedly mounted within second port 17.

Device 11 additionally comprises a metal hub or tip 25. Tip 25 is agenerally tubular member having a proximal end 27 and a distal end 29. Aplurality of external barbs 31 are formed on tip 25 intermediate toproximal end 27 and distal end 29. Proximal end 27 and barbs 31 aremounted within catheter 21 proximate to distal end 23, with distal end29 of tip 25 not being inserted into catheter 21, but rather, externallyabutting distal end 23 of catheter 21.

Device 11 further comprises a flexible wire 35, wire 35 having aproximal end 37 and a distal end 39. Proximal end 37 of wire 35 is fixedto a cap 41, cap 41 being adapted to be screwed onto first port 15 ofbody 13. The remainder of wire 35 is threaded through ports 15 and 17 ofbody 13 and into catheter 21, with distal end 39 of wire 35 beingdisposed within catheter 21 proximate to distal end 23. A stop (notshown) is provided on wire 35, said stop being engageable with body 13to delimit proximal movement of wire 35.

Device 11 also comprises a histology sampling needle 51, needle 51having a proximal end 53 and a distal end 55. Proximal end 53 of needle51 is fixed to distal end 39 of wire 35. Distal end 55 of needle 51 isshaped to include a sharp tip. A bore 57 extends proximally from distalend 55 of needle 51 to a side opening 59 proximate to proximal end 53.An annular seal 61 is mounted over needle 51 just distal to side opening59, seal 61 being adapted to abut proximal end 27.

Device 11 may be used essentially in the fashion described above toobtain a tissue sample. To place needle 51 in its advanced position,i.e., so that distal end 55 of needle 51 extends beyond tip 25, onemoves cap 41 distally and screws cap 41 onto port 15. Conversely, towithdraw or to retract needle, i.e., so that distal end 53 of needle 51is disposed within tip 25, one unscrews cap 41 from port 15 and movescap 41 proximally relative to body 13 until restrained by theaforementioned stop.

Although device 11 is satisfactory in many respects, the presentinventors have identified certain shortcomings therewith. One suchshortcoming is that, whereas device 11 includes means for retainingneedle 51 in its extended position (namely, by screwing cap 41 onto port15), device 11 does not include corresponding means for retaining needle51 in a retracted position. Consequently, if one wishes to ensure thatneedle 51 is not advanced through distal end 23 of catheter 21 at aninopportune moment, one must constantly pull cap 41 proximally relativeto body 13. However, as can readily be appreciated, such a requirementsubstantially complicates the manipulation of device 11, especially byan individual operator.

Another shortcoming identified by the present inventors with device 11is the branched shape of body 13 and the resultant orientation of asyringe coupled thereto through port 19. More specifically, the presentinventors have found that the perpendicular orientation of a syringerelative to the longitudinal axis of catheter 21 makes device 11cumbersome and difficult to manipulate by an individual operator.

Yet another shortcoming identified by the present inventors with device11 is that, when needle 51 is in its extended position and a load forceis applied to the distal end 53 of needle 51 (such as is the case whenneedle 51 is used to penetrate a tissue), needle 51 tends to be movedproximally relative to catheter 21, thereby effectively shortening theusable length of needle 51 for penetrating the tissue. Such a loss inthe usable length of needle 51 occurs because wire 35 has an outerdiameter that is considerably smaller than the inner diameter ofcatheter 21, giving wire 35 room to move laterally within catheter 21.Consequently, when catheter 21 is bent, as is the case when device 11 isdeployed in a patient, and a load force is applied to needle 51, wire 35tends to take the longest possible path through catheter 21.

Conversely, when cap 41 is pulled back relative to catheter 21 to itsfully retracted position and catheter 21 is bent to a substantialdegree, needle 51 may not fully retract relative to catheter 21. This isbecause of the aforementioned difference between the outer diameter ofwire 35 and the inner diameter of catheter 21 and the tendency of wire35 to take the shortest possible path through catheter 21. As canreadily be appreciated, if needle 51 cannot be fully retracted whensampling is not being performed, damage may occur to equipment,operators and/or the patient.

Still another shortcoming identified by the present inventors withdevice 11 is that tip 25 is susceptible to becoming dislodged distallyfrom catheter 21. As can readily be appreciated, if tip 25 were tobecome separated from catheter 21, the risks to the patient would beconsiderable. Such a susceptibility of tip 25 to becoming dislodged isdue, in part, to the fact that tip 25 is held within catheter 21 only bythe friction-fit of catheter 21 over barbs 31 and proximal end 27. Thissusceptibility is exacerbated by the fact that, when needle 51 isadvanced to its extended position, seal 61 applies a distally directedforce against tip 25. In addition, because catheter 21 has a tendency tobulge radially outwardly in the area where it overlies barbs 31, thisbulged area of catheter 21 is susceptible to becoming snagged on thedistal end of a bronchoscope when device 11 is retracted into thebronchoscope. Such snagging results in additional distally directedforce being applied to tip 25 relative to catheter 21.

Still yet another shortcoming identified by the present inventors withdevice 11 is that distal end 29 of tip 25, which is not disposed withincatheter 21, but rather, lies externally thereto, has a tendency toscratch and, thus, to damage the working channel of a bronchoscope.

Still a further shortcoming identified by the present inventors withdevice 11 is that, when needle 51 is retracted, distal end 55 of needle51 has a tendency to be withdrawn proximally from hub 25. This requiresneedle 51 to be re-aligned properly with hub 25 in order for needle 51to be re-inserted into hub 25.

Still yet a further shortcoming identified by the present inventors withdevice 11 is that seal 61 often does not create an air-tight sealagainst tip 25 when needle 51 is placed in its fully extended position;as a result, the full extent of the vacuum force applied to bore 57 ofneedle 51 by the syringe is frequently not experienced.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a tissue samplingdevice suitable for use in transbronchial needle aspiration (TBNA).

It is another object of the present invention to provide a tissuesampling device as described above that overcomes at least some of theshortcomings associated with existing TBNA devices.

It is still another object of the present invention to provide a deviceas described above that can be mass-produced relatively inexpensively,that has a minimal number of parts, and that is easy to operate.

In furtherance of the above and other objects to be described or tobecome apparent from the description below, there is provided, accordingto one aspect of the invention, a tissue sampling device suitable foruse in transbronchial needle aspiration, said tissue sampling devicecomprising (a) a flexible catheter, said flexible catheter having aproximal end and a distal end; (b) a sampling needle, said samplingneedle being insertable into said flexible catheter and being shaped toinclude a distal tip; (c) means coupled to said sampling needle formoving said sampling needle between a first position wherein said distaltip of said sampling needle is disposed within said flexible catheterand a second position wherein said distal tip of said sampling needleextends distally beyond said distal end of said flexible catheter; and(d) means for retaining said sampling needle at said first position in areleasably locked fashion.

According to another aspect of the invention, there is provided a tissuesampling device suitable for use in transbronchial needle aspiration,said tissue sampling device comprising (a) a flexible catheter, saidflexible catheter having a proximal end and a distal end; (b) a samplingneedle, said sampling needle being disposed at said distal end of saidflexible catheter and having a distal tip; and (c) a handle assembly,said handle assembly being secured to said proximal end of said flexiblecatheter, said handle assembly including a port adapted to receive asyringe in such a manner as to fluidly interconnect said syringe to saidflexible catheter, said port being oriented parallel to said proximalend of said flexible catheter.

According to yet another aspect of the invention, there is provided atissue sampling device suitable for use in transbronchial needleaspiration, said tissue sampling device comprising (a) a flexiblecatheter, said flexible catheter having a proximal end, a distal end andan inner diameter; (b) a wire, said wire extending substantiallycoaxially within said flexible catheter, said wire having a proximalend, a distal end and an outer diameter, said outer diameter of saidwire being substantially less than said inner diameter of said flexiblecatheter; (c) a sampling needle, said sampling needle being positionedat said distal end of said flexible catheter and being coupled to saiddistal end of said wire; (d) means inserted over at least a portion ofsaid wire for centering said wire within said flexible catheter whilestill providing a space for fluid flow; and (e) a handle assembly, saidflexible catheter being fixed at said proximal end to said handleassembly.

According to still yet another aspect of the invention, there isprovided a tissue sampling device suitable for use in transbronchialneedle aspiration, said tissue sampling device comprising (a) a flexiblecatheter, said flexible catheter having a proximal end and a distal end;(b) a hub, said hub being substantially tubular and having a proximalend and a distal end, said hub being disposed within said flexiblecatheter, with said distal end of said flexible catheter being invertedso as to retain said hub distally within said flexible catheter; (c) asampling needle, said sampling needle having a tip; and (d) meanscoupled to said sampling needle for moving said sampling needle betweena first position wherein said tip of said sampling needle is disposedwithin said hub and a second position wherein said tip of said samplingneedle extends distally beyond said distal end of said flexiblecatheter.

According to a further aspect of the invention, there is provided atissue sampling device suitable for use in transbronchial needleaspiration, said tissue sampling device comprising (a) a flexiblecatheter, said flexible catheter having a proximal end, a distal end andan inner diameter; (b) a wire, said wire extending within said flexiblecatheter, said wire having a proximal portion and a distal portion, saiddistal portion having a decreased thickness as compared to said proximalportion; (c) a sampling needle, said sampling needle being positioned atsaid distal end of said flexible catheter and being coupled to saidwire; and (d) a compressed spring surrounding and secured to at least aportion of said distal portion of said wire.

According to still a further aspect of the invention, there is provideda tissue sampling device suitable for use in transbronchial needleaspiration, said tissue sampling device comprising (a) a handle, saidhandle comprising a body and a cover, said body and said cover togetherdefining a top, a bottom and a distal end, said top having a slot, saiddistal end having a bore; (b) a button slide, said button slide beingslidably mounted in said handle and including a button, said buttonextending upwardly through said slot for manipulation by an operator;(c) a flexible catheter, said flexible catheter having a proximal endand a distal end, said proximal end being mounted within said bore insaid handle; (d) a wire, said wire having a proximal end and a distalend, said proximal end of said wire being coupled to said button slide;and (e) a sampling needle, said sampling needle being coupled to saiddistal end of said wire, said sampling needle having a distal tip; (f)wherein said button slide is movable between a first position in whichsaid distal tip of said sampling needle is positioned within saidflexible catheter and a second position in which said distal tip of saidsampling needle extends distally past said proximal end of said flexiblecatheter.

According to still yet a further aspect of the invention, there isprovided a tissue sampling device suitable for use in transbronchialneedle aspiration, said tissue sampling device comprising (a) a flexiblecatheter, said flexible catheter having a proximal end and a distal end;(b) a hub, said hub being substantially tubular and having a proximalend and a distal end, said hub being disposed within said flexiblecatheter proximate to said distal end thereof; (c) a sampling needle,said sampling needle having a distal tip and a shoulder; and (d) meanscoupled to said sampling needle for moving said sampling needle betweena first position wherein said distal tip of said sampling needle isdisposed within said hub and a second position wherein said distal tipof said sampling needle extends distally beyond said distal end of saidflexible catheter; (e) wherein said shoulder of said sampling needle isadapted to directly abut said proximal end of said hub to form a sealtherewith when said sampling needle is placed in said second position.

For purposes of the present specification and claims, various relationalterms like “top,” “bottom,” “proximal,” “distal,” “upper,” “lower,”“front,” and “rear” are used to describe the present invention when saidinvention is positioned in a given orientation. It is to be understoodthat, by altering the orientation of the invention, certain relationalterms may need to be adjusted accordingly.

Additional objects, as well as features and advantages, of the presentinvention will be set forth in part in the description which follows,and in part will be obvious from the description or may be learned bypractice of the invention. In the description, reference is made to theaccompanying drawings which form a part thereof and in which is shown byway of illustration various embodiments for practicing the invention.The embodiments will be described in sufficient detail to enable thoseskilled in the art to practice the invention, and it is to be understoodthat other embodiments may be utilized and that structural changes maybe made without departing from the scope of the invention. The followingdetailed description is, therefore, not to be taken in a limiting sense,and the scope of the present invention is best defined by the appendedclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are hereby incorporated into andconstitute a part of this specification, illustrate various embodimentsof the invention and, together with the description, serve to explainthe principles of the invention. In the drawings wherein like referencenumerals represent like parts:

FIG. 1 is a perspective view of a conventional transbronchial needleaspiration (TBNA) device;

FIG. 2 is a fragmentary, section view of the TBNA device of FIG. 1,showing the distal portion thereof;

FIG. 3 is a side view of one embodiment of a TBNA device constructedaccording to the teachings of the present invention, the TBNA devicebeing shown with its needle in the retracted position;

FIG. 4 is a fragmentary longitudinal section view of the TBNA device ofFIG. 3, the TBNA device being shown with its needle in the retractedposition;

FIG. 5 is an exploded perspective view of the TBNA device of FIG. 3;

FIGS. 6(a) and 6(b) are fragmentary section views of the TBNA device ofFIG. 3, showing the distal portion thereof with the needle in itsretracted and extended positions, respectively;

FIGS. 7(a) through 7(f) are perspective, side, top, proximal, distal andlongitudinal section views, respectively, of the handle body shown inFIG. 3;

FIGS. 8(a) through 8(e) are perspective, top, bottom, left longitudinalsection and right longitudinal section views, respectively, of thehandle cover shown in FIG. 3;

FIGS. 9(a) through 9(e) are perspective, top, bottom, right side andleft longitudinal section views, respectively, of the button slide shownin FIG. 3;

FIG. 10(a) through 10(e) are perspective, proximal, distal, right sideand left longitudinal section views, respectively, of the syringeconnector shown in FIG. 3;

FIGS. 11 (a) through 11 (d) are perspective, proximal, right side andright longitudinal section views, respectively, of the strain reliefmember shown in FIG. 3;

FIGS. 12(a) and 12(b) are perspective and right longitudinal sectionviews, respectively, of the hub shown in FIG. 3;

FIG. 13 is a fragmentary right side view of the wire shown in FIG. 3;

FIGS. 14(a) and 14(b) are proximal and side views, respectively, of thejacket shown in FIG. 3;

FIGS. 15(a) and 15(b) are right side and enlarged right longitudinalsection views, respectively, of the spring shown in FIG. 3;

FIGS. 16(a) through 16(c) are fragmentary right side, fragmentary rightlongitudinal section and fragmentary enlarged right longitudinal sectionviews, respectively, of the combination of the wire, the jacket and thespring shown in FIG. 3;

FIG. 16(d) is an enlarged right side view showing the distal ends of thespring and the wire shown in FIG. 16(a);

FIGS. 17(a) through 17(d) are perspective, left side, top and enlargedfragmentary left longitudinal section views, respectively, of the needleshown in FIG. 3;

FIGS. 18(a) through 18(c) are perspective, top and left side views,respectively, of a first alternate needle; and

FIGS. 19(a) through 19(c) are perspective, top and left side views,respectively, of a second alternate needle.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now to FIGS. 3, 4, 5, 6(a) and 6(b), there are shown variousviews, respectively, of one embodiment of a transbronchial needleaspiration (TBNA) device constructed according to the teachings of thepresent invention, said TBNA device being represented generally byreference numeral 101.

Device 101 comprises a handle assembly 103, a wire 105, a flexiblecatheter 107, a sampling needle 109, a hub 111, a jacket 113 and aspring 115.

Handle assembly 103, in turn, comprises a body 117, a cover 119, abutton slide 121, a syringe connector 123 and a strain relief member125.

Referring now to FIGS. 7(a) through 7(f), body 117 is a unitary,generally C-shaped member, preferably made of a durable molded plasticor another similarly suitable material, comprising a top portion 131, adistal end portion 133 and a bottom portion 135, the sides and proximalend of body 117 being open. Top portion 131, distal end portion 133 andbottom portion 135 collectively define a longitudinally-extending cavity139, which, as will be described below, is shaped to accommodate asyringe or similar aspirating device.

Top portion 131 is shaped to include a pair of rails 141-1 and 141-2,rails 141-1 and 141-2 being separated by a slot 142 whose purpose willbecome apparent below. A first pair of detents 143-1 and 143-2 areformed on the outer side surface of rail 141-1, and a second pair ofdetents 145-1 and 145-2 are formed on the outer side surface of rail141-2, second detents 145-1 and 145-2 being staggered relative to firstdetents 143-1 and 143-2. As will be described below, detents 143-1,143-2, 145-1 and 145-2 are used in the coupling together of body 117 andcover 119 to form a handle.

Distal end portion 133 includes a proximal surface 147, proximal surface147 being shaped to receive syringe connector 123. Distal end portion133 also includes a distally extending post 149. A bore 151 (which isseen best in FIG. 7(f)) extends longitudinally through post 149 andcontinues through the remainder of distal end portion 133 to cavity 139.Bore 151 includes a distal portion 151-1 of comparatively greatercross-sectional diameter and a proximal portion 151-2 of comparativelylesser cross-sectional diameter, distal portion 151-1 extending for mostof the length of bore 151. As will be described further below, distalportion 151-1 is sized to securely receive the proximal end of catheter107, with the proximal end of wire 105 passing through proximal portion151-2. A transverse opening 153 is also provided in distal end portion133, transverse opening 153 intersecting distal portion 151-1 of bore151 at an intermediate location thereof.

Bottom portion 135 has a top surface 155 and a bottom surface 157. Topsurface 155 is contoured to receive a syringe or similar aspiratingdevice thereon. Bottom surface 157 is contoured to fit ergonomicallywithin the hand of an operator.

Referring now to FIGS. 8(a) through 8(e), cover 119 is a unitary,generally trough-shaped member, preferably made of a durable moldedplastic or another similarly suitable material, comprising a top portion161, a pair of side portions 163-1 and 163-2, and a proximal end portion165, the bottom and the distal end of cover 119 being open. Top portion161 is shaped to include an elongated, longitudinally-extending slot167, through which, as will be further described below, the buttonportion of button slide 121 is adapted to extend. Top portion 161 isalso shaped to include a proximal pair of notches 169-1 and 169-2 and adistal pair of notches 171-1 and 171-2, notches 169-1 and 169-2 beingdisposed on opposite sides of slot 167 near the proximal end thereof,notches 171-1 and 171-2 being disposed on opposite sides of slot 167near the distal end thereof. As will be described further below,proximal notches 169-1 and 169-2 and distal notches 171-1 and 171-2 arealternately adapted to receive, in a releasably locking fashion, a pairof pawls formed on button slide 121, notches 169-1 and 169-2 beingadapted to receive said pawls in such a manner as to retain button slide121 at a proximal position (as in FIGS. 3, 4 and 6(a)), notches 171-1and 171-2 being adapted to receive said pawls in such a manner as toretain button slide 121 at a distal position (as in FIG. 6(b)).

A first pair of recesses 175-1 and 175-2 are formed on the insidesurface of side portion 163-1, and a second pair of recesses 177-1 and177-2 are formed on the inside surface of side portion 163-2. Recesses175-1 and 175-2 are adapted to securely receive detents 143-1 and 143-2,respectively, of rail 141-1, and recesses 177-1 and 177-2 are adapted tosecurely receive detents 145-1 and 145-2, respectively, of rail 141-2.In this manner, body 117 and cover 119 may be secured to one another toform a handle. With body 117 and cover 119 thus coupled together,proximal end portion 165 of cover 119 is situated within the openproximal end of body 117, the open distal end of cover 119 terminatesjust proximally of post 149, and top portion 161 of cover 119 is spaced,for reasons to become apparent below, from the top surfaces of rails141-1 and 141-2.

Referring now to FIGS. 9(a) through 9(e), button slide 121 is a unitary,generally rectangular member, preferably made of a durable moldedplastic or other similarly suitable material, comprising an outer frameportion 181 and an inner tab portion 183. Frame portion 181, which isgenerally planar, is shaped to include a proximal end 185, a distal end187, and a pair of sides 189-1 and 189-2, all of which collectivelydefine an interior cavity 190. For reasons to become apparent below,frame portion 181 is appropriately dimensioned so that sides 189-1 and189-2 are adapted to ride along the top surfaces of rails 141-1 and141-2, respectively, and below a pair of ribs 188-1 and 188-2,respectively, formed on cover 119 (see FIGS. 8(c) through 8(e)).

Proximal end 185 of frame 181 is shaped to include a downwardlyextending central portion 191, central portion 191 being dimensioned toextend downwardly a short distance through slot 142 of body 117. A slot193 is provided in central portion 191, slot 193 extending upwardly ashort distance from the bottom surface of portion 191. Slot 193 isshaped to include a pair of substantially orthogonal arms 193-1 and193-2, which, as will be described further below, are adapted tomatingly receive the proximal end of wire 105.

Distal end 187 is shaped to include a generally rectangular centralportion 195, central portion 195 being dimensioned to extend downwardlya short distance through slot 142. A bore 197 is provided in centralportion 195, bore 197 being aligned with arm 193-1 of slot 193 toreceive an intermediate length of wire 105.

Inner tab portion 183 is generally trapezoidal in shape and includes aproximal end 201, a distal end 203 and a pair of sides 205-1 and 205-2.Proximal end 201 is hingedly connected to proximal end 185 of frame 181,with distal end 203 being free and upwardly biased. A pair of pawls207-1 and 207-2 extend upwardly from sides 205-1 and 205-2,respectively, of tab portion 183. Pawls 207-1 and 207-2 are adapted tobe received either within proximal notches 169-1 and 169-2,respectively, or distal notches 171-1 and 171-2, respectively, of cover119.

A button 209 is provided on the top surface of tab portion 183 proximateto distal end 203, button 209 being adapted to extend upwardly throughslot 167 of cover 119. With button 209 thus accessible through slot 167,an operator may use button 209 to exert downward pressure on tab portion183 to disengage pawls 207-1 and 207-2 from either notches 169-1 and169-2 or notches 171-1 and 171-2, as well as to slide button slide 121proximally or distally along rails 141-1 and 141-2. Gripping elements211 extend outwardly from the top of button 209 to facilitatemanipulation of button 209.

Referring now to FIGS. 10(a) through 10(e), syringe connector 123 is agenerally teardrop-shaped unitary member, preferably made of a durablemolded plastic or another similarly suitable material, comprising aproximal end 221, a distal end 223 and a side 225. A port 227 extendsproximally a short distance from proximal end 221, port 227 defining atapered cavity 229 adapted to receive the medical luer of a syringe. Theproximal end of port 227 is shaped to include a pair of radiallyoutwardly extending tabs 229-1 and 229-2, tabs 229-1 and 229-2 beingadapted for threaded engagement with the internally threaded sleeve of asyringe. Port 227 is oriented so that, with a syringe connected theretoand with connector 123 mounted on body 117, said syringe extendslongitudinally through cavity 139 and on top of bottom portion 155 ofbody 117.

An oval-shaped ridge 231 extends distally a short distance from distalend 223, ridge 231 being receivable within a correspondingly shapedgroove 235 provided in distal end portion 133 of body 117 (see FIG.7(d)). An adhesive (not shown) may be used, if desired, to more securelyretain ridge 231 within groove 235. Ridge 231 defines an oval-shapedcavity 237 that is adapted to bounded proximally by distal end 223 ofsyringe connector 123 and distally by distal end portion 133 of body117. Cavity 237 is adapted to be aligned with distal portion 151-1 ofbore 151 of body 117 for reasons to become apparent below.

A first transverse bore 241 extending between proximal end 221 anddistal end 223 is provided in syringe connector 123, bore 241 being influid communication with each of cavity 229 and cavity 237. Accordingly,by connecting a syringe to connector 121, one can apply negative orpositive suction force through cavity 229, bore 241, and cavity 237 andinto bore 151.

A second transverse bore 245 extending between proximal end 221 anddistal end 223 is provided in syringe connector 123, bore 245 beingalignable with bore 151 for an intermediate portion of wire 105 to passtherethrough.

Referring now to FIGS. 11 (a) through 11 (d), strain relief member 125is a unitary member, preferably made of a durable molded plastic oranother similarly suitable material, comprising a generally cylindricalproximal portion 251 and a frustoconical distal portion 253. Alongitudinal bore 255 extends the length of member 125, the proximalportion 256 of bore 255 being shaped to receive, among other things,post 149 of body 117, the distal portion 257 of bore 255 being shaped toreceive, and thereby provide strain relief to, a length of catheter 107proximate to the proximal end of catheter 107.

Referring now to FIGS. 12(a) and 12(b), hub 111 is a unitary tubularmember, preferably made of stainless steel or another similarly suitablematerial, comprising a proximal portion 261 and a distal portion 263.Proximal portion 261 is straight and has a uniform diameter over itsentire length. Distal portion 263 flares outwardly from proximal portion261 to a distal end 265 for reasons to become apparent below. (It shouldbe understood that the proximal end could also be outwardly flared, ifdesired.) Referring back to FIGS. 3, 4, 5, 6(a) and 6(b), catheter 107is a unitary flexible tubular member, preferably made of nylon oranother similarly suitable material, having a length of about 160 cm andcomprising a proximal end 271 and a distal end 273. Proximal end 271 ofcatheter 107 is coaxially received and fixedly secured within distalportion 151-1 of bore 151. As seen best in FIGS. 6(a) and 6(b), catheter107 is dimensioned relative to hub 111 so that hub 111 may be press-fitinto catheter 107 through distal end 273, with distal end 273 ofcatheter 107 being inverted over distal end 265 of hub 111 and shaped todefine an opening 275. Although not shown herein, the shaping of distalend 273 of catheter 107 around distal end 265 of hub 111 to defineopening 275 may be performed by inserting a mandrel through hub 111 andcatheter 107 and then using heat to shape distal end 273 to saidmandrel. Preferably, opening 275 of catheter 107 is dimensioned toconform closely to the outer diameter of a shaft 277 of needle 109 topromote an air-tight seal between shaft 277 and catheter 107 when needle109 is extended through opening 275 (as in FIG. 6(b)). Alternatively,one could position an annular seal (not shown) coaxially within catheter107 between distal end 273 of catheter 107 and distal end 265 of hub111, said annular seal being appropriately dimensioned and made of asuitable material to promote an air-tight interface with the outersurface of needle 109 inserted therethrough.

Referring now to FIG. 13, wire 105 is a solid flexible unitary member,preferably made of stainless steel or another similarly suitablematerial, comprising a proximal portion 281 and a distal portion 283.Proximal portion 281, which has a length of about 52 inches and athickness of about 0.022 inch, includes a proximal end 285. Proximal end285 is bent into an L-shape and is adapted to be securely receivedwithin slot 193 of button slide 121. The remainder of proximal portion281 is adapted to be inserted through bore 197 of button slide 121,through an annular seal 291 (see FIGS. 4 and 5) positioned betweenbutton slide 121 and syringe connector 123, through bore 245 of syringeconnector 123, through bore 151 of body 103 and into catheter 107,terminating a few inches proximally of hub 111.

Distal portion 283, which has a length of about 2 inches, is shaped toinclude a proximal segment 287-1 and a distal segment 287-2. Proximalsegment 287-1 has a length of about 0.2 inch and decreases uniformly inthickness from about 0.022 inch at its proximal end to about 0.01 inchat its distal end. Distal segment 287-2, which extends distally fromsegment 287-1, has a length of about 1.8 inch and a uniform thickness ofabout 0.01 inch over its entire length.

As will be described further below, the reason for providing a reducedthickness over much of the length of distal portion 283 of wire 105 isto endow distal portion 283 with additional flexibility, which may beadvantageous in enabling distal portion 283 to be delivered to certainremote sampling sites accessible only through contorted paths. Endowingdistal portion 283 of wire 105 with additional flexibility may also beadvantageous in allowing passage through aggressive scope channels.Notwithstanding the above, distal portion 283 may be varied in sizeand/or shape depending upon the characteristics desired therefor.

Referring now to FIGS. 14(a) and 14(b), jacket 113 is a unitary tubularmember, preferably made of arnitel, polypropylene or another similarlysuitable material. Jacket 113 is shaped to include a proximal end 301, adistal end 303, a central bore 305, and a plurality of external ribs307-1 through 307-4. Bore 305 is appropriately dimensioned to securelyreceive wire 105 by a friction-fit, with proximal end 301 of jacket 113being aligned with that portion of wire 105 that is disposed withindistal portion 151-1 of bore 151 when button slide 121 is in itsretracted position and with distal end 303 of jacket 113 being alignedwith that portion of wire 105 that is positioned just proximally ofdistal portion 283. An alternative to the aforementioned friction-fitbetween wire 105 and jacket 113 is a sliding-fit between wire 105 andjacket 113. Such a sliding-fit allows wire 105 to move with respect tojacket 113 in situations where jacket 113 encounters resistance whensliding within catheter 107. This allows for movement of wire 105 tooccur in the manner of least resistance.

Ribs 307-1 through 307-4, which extend longitudinally along the entirelength of jacket 113, are evenly spaced about the circumference ofjacket 113. Each of ribs 307-1 through 307-4 extends in a directionradially outwardly from bore 305 and is generally triangular in shape,as viewed from an end of jacket 113. Ribs 307-1 through 307-4 areappropriately sized so that at least one of their respective vertices309-1 through 309-4 is adapted to be in contact with the inside surfaceof catheter 107. In this manner, ribs 307-1 through 307-4 serve to keepwire 105 substantially centered within catheter 107 throughout itslength (even when a load force is applied to needle 109) while, at thesame time, providing ample space (i.e., between adjacent ribs 307) forfluid flow within catheter 107.

As can readily be appreciated, there are a myriad number of ways inwhich ribs 307-1 through 307-4 may be changed in size, shape and numberwhile still satisfying the foregoing objectives of keeping wire 105centered within catheter 107 and providing an ample volume withincatheter 107 for fluid flow. (For examples of these and othermodifications, see commonly-assigned U.S. Pat. No. 6,454,702 andcommonly-assigned U.S. patent application Ser. No. 09/716,710, both ofwhich are incorporated herein by reference.)

In another embodiment (not shown), one could replace jacket 113 with aplurality of beads or similarly suitable elements over-molded aroundwire 105 at spaced intervals thereof, said beads being sized to engagethe inside surface of catheter 107 and, thus, to keep wire 105 centeredwithin catheter 107. If desired, said beads could have longitudinalgrooves or channels oriented along the longitudinal axis of catheter 107to allow maximum fluid flow from the proximal to the distal portions ofcatheter 107 and vice versa. The dimensions of said beads may also bechosen so as to regulate fluid flow by controlling the gap between thebead surface and catheter 107.

In still another embodiment (not shown), one could replace both jacket113 and wire 105 with a wire that is shaped (e.g., by machining,stamping, etc.) to include one or more elements adapted to keep saidwire centered within catheter 107.

Referring now to FIGS. 15(a) and 15(b), spring 115 is a unitary member,preferably made of stainless steel or another similarly suitablematerial, comprising a plurality of closely spaced or compressed coils311 terminating at a proximal end 313 and a distal end 315. (Althoughcoils 311 are shown in the present embodiment having a rectangulartransverse cross-sectional shape, it is to be understood that coils 311are not limited to a rectangular transverse cross-sectional shape andcould have, for example, a circular transverse cross-sectional shape orthe like.) As seen best in FIGS. 16(a) through 16(c), spring 115coaxially surrounds distal portion 283 of wire 105, with proximal end313 of spring 115 being secured, preferably by a weld 314-1 (see FIG.16(c)) or like means, to wire 105 just proximally of segment 287-1 andwith distal end 315 of spring 115 being secured, preferably by a weld314-2 (see FIG. 16(d)) or like means, to the distal end of segment287-2. Spring 115 has a uniform inner diameter of about 0.026 inch,which is slightly greater than the thickness of wire 105, and a uniformouter diameter of about 0.034 inch.

The purpose of spring 115 is to provide greater column strength todistal portion 283 of wire 105, i.e., to make distal portion 283 lesslikely to buckle when a compressive force is applied thereto. Suchincreased column strength is desirable since, as noted above, distalportion 283 has a decreased thickness as compared to the remainder ofwire 105. One advantageous feature of spring 115 is that, whereas spring115 cannot be compressed and, therefore, provides the aforementionedcolumn strength to distal portion 283, spring 115 can be bent and,therefore, does not substantially diminish the flexibility of distalportion 283.

Referring now to FIGS. 17(a) through 17(d), needle 109 is a unitarymember, preferably made of stainless steel or another similarly suitablematerial, comprising a proximal base portion 321 and a distal stemportion 323. Base portion 321, which is generally cylindrical in shape,is about 0.2 inch in length and includes a proximal end 325, a roundeddistal end 327, a longitudinal bore 329 and an upwardly-facing slot 331,slot 331 extending distally from proximal end 325 to a point just priorto distal end 327. Slot 331 is bounded by a flat edge 332 onto whichwire 105 may be secured, preferably by welding or like means.

Stem portion 323, which is generally cylindrical in shape and coaxialwith base portion 321, is about 0.8 inch in length and includes aproximal end 333, a distal end 335 and a longitudinal bore 337. Distalend 335 is shaped to define an upwardly-facing, open-ended tip, said tipbeing appropriately shaped and dimensioned to acquire a tissue samplefor biopsy. As in the embodiment shown, slot 331 and the tip of needle109 both face in the same direction; in this manner, wire 105 may be(but is not necessarily) welded to needle 109 on the same side as thetip. This permits force applied to the tip to be transmitted along theaxis of wire 105. When joining wire 105 to needle 109, a small space isleft between the distal end of wire 105 and the distal end of slot 331,said space being appropriately sized to permit fluid flow betweencatheter 107 and longitudinal bores 337 and 329 of needle 109 while, atthe same time, preventing passage of the sample from needle 109 intocatheter 107. This gap may be varied in size and/or length to regulatefluid flow for a given purpose.

Rounded distal end 327 of base portion 321 and proximal end 333 of stemportion 323 together define a shoulder that is shaped to abut directlythe proximal end of hub 111 in such a way as to form an air-tight sealtherewith when needle 109 is placed in its advanced position.

As discussed above, the outer diameter of stem portion 323 isappropriately dimensioned to form a tight seal with distal end 273 ofcatheter 107 when needle 109 is moved to its extended position (see FIG.6(b)). In addition, as noted above, the shoulder formed by roundeddistal end 327 of base portion 321 and proximal end 333 of stem portion323 is appropriately dimensioned to engage proximal end 261 of hub 111so as to form a seal therewith, as well as to delimit distal movement ofneedle 109 (and, in so doing, prevent needle 109 from being lostdistally from the remainder of device 101 and, perhaps, becoming lost ina patient). Although not shown, one could, if desired, enhance the sealformed between the shoulder of needle 109 and proximal end 261 of hub111 by heat-shrinking an elastomeric sleeve over the shoulder of needle109, said sleeve conforming to the shape of the shoulder and forming asealing interface with the proximal end 261 of hub 111. (It should benoted that the use of such an elastomeric sleeve in device 101 wouldmake considerably more difficult any reprocessing of device 101.)

Referring now to FIGS. 18(a) through 18(c), there are shown variousviews of a first alternate needle usable instead of needle 109 in device101, said first alternate needle being constructed according to theteachings of the present invention and being represented generally byreference numeral 359.

Needle 359 is a unitary structure shaped to include a stem portion 361and abase portion 363. Stem portion 361, which is substantiallyidentical to stem portion 323 of needle 109, is a generally tubularelement shaped to include a proximal end 365 and a distal end 367,distal end 367 being an upwardly-facing, open-ended tip.

Base portion 361 includes a distal portion 369 and a proximal portion.Distal portion 369, which is generally tubular in shape, forms ashoulder with proximal end 365 of stem portion 361. The proximal portionof base portion 361 is bifurcated into a left side member 373 and aright side member 375, left side member 373 and right side member 375being centered relative to the top and bottom surfaces of distal portion369 of base portion 361. Wire 105 may be mounted along the top or bottomsurfaces of left and right side members 373 and 375, respectively.

Referring now to FIGS. 19(a) through 19(c), there are shown variousviews of a second alternate needle usable instead of needle 109 indevice 101, said second alternate needle being constructed according tothe teachings of the present invention and being represented generallyby reference numeral 379.

Needle 379 is a unitary structure shaped to include a stem portion 381and a base portion 383. Stem portion 381, which is substantiallyidentical to stem portion 323 of needle 109, is a generally tubularelement shaped to include a proximal end 385 and a distal end 387,distal end 387 being an upwardly-facing, open-ended tip.

Base portion 383 is a generally tubular element shaped to include atransverse slot 389 extending distally a short distance from theproximal end of base portion 383. Slot 389, which is appropriately sizedfor wire 105 to be mounted therewithin, extends from the left side ofbase portion 383 to the right side of base portion 383 and is centeredrelative to the top and bottom surfaces of base portion 383.

One desirable attribute of needle 379 is that slot 389 permits wire 105to be coupled to needle 379 in such a way that wire 105 and needle 379share a common axis.

In use, prior to inserting device 101 into a bronchoscope, an operatortypically tests device 101 by using button slide 121 to alternatelyposition needle 109 in its advanced position and its retracted position.Once the operability of said needle positioning mechanism has beenconfirmed, needle 109 is then locked in its retracted position bypositioning slide 121 so that pawls 207-1 and 207-2 are positionedwithin notches 169-1 and 169-2, respectively. The distal end of device101 is then loaded into a bronchoscope (which has previously beeninserted into the patient to a neutral location), and a syringe isattached to port 227 of connector 123. Once confirmation is receivedthat distal end 273 of device 101 has passed entirely through thebronchoscope (such confirmation typically being provided using a videochannel of the same bronchoscope), the bronchoscope and device 101 areadvanced together to the target site, and needle 109 is advanced to itsextended position by positioning slide 121 so that pawls 207-1 and 207-2are positioned within notches 171-1 and 171-2, respectively. Distal end335 of needle 109 is then inserted through the bronchial wall of thepatient and into a nearby lymph node. At this time, the syringe is usedto apply suction. In the unfortunate event that needle 109 has errantlypenetrated a blood vessel, instead of a lymph node, the application ofsuction causes blood to be aspirated through bore 337 of needle 109 andinto catheter 107 and the syringe, where such blood is detected. In sucha case, the application of suction is discontinued and the soiled device101 is removed from the bronchoscope and the patient. A fresh TBNAdevice 101 is then loaded into the bronchoscope and the patient in themanner described above, and another attempt is made to penetrate thelymph node.

If, while suction is applied, it appears that needle 109 has penetrateda lymph node, as is desired, catheter 107 is agitated to help sheartissue from the penetrated lymph node into bore 337 of needle 109. Witha tissue sample thus disposed within bore 337 of needle 109, needle 109is moved back to its retracted position within catheter 107 bypositioning slide 121 so that pawls 207-1 and 207-2 are positionedwithin notches 169-1 and 169-2, respectively. Device 101 is then removedfrom the bronchoscope and the patient. Needle 109 is then placed in itsadvanced position by positioning slide 121 so that pawls 207-1 and 207-2are positioned within notches 171-1 and 171-2, respectively, andnegative suction is then used to expel the tissue from needle 109 onto aslide or the like for histological examination.

Device 101 is intended to be a single-use device. However, it isenvisioned that, if device 101 is constructed from materials capable ofwithstanding reprocessing conditions, e.g., flushing with suction,followed by (or preceded by) washing in an ultrasonic bath, flushingagain with suction, and then autoclaving, device 101 may be reprocessedfor additional use.

The embodiments of the present invention described above are intended tobe merely exemplary and those skilled in the art shall be able to makenumerous variations and modifications to it without departing from thespirit of the present invention. All such variations and modificationsare intended to be within the scope of the present invention as definedin the appended claims.

1. A tissue sampling device, said tissue sampling device comprising: (a) a flexible catheter, said flexible catheter having a proximal end and a distal end; (b) a hub, said hub being substantially tubular and having a proximal end and a distal end, said hub being disposed within said flexible catheter, with said distal end of said flexible catheter being inverted so as to retain said hub distally within said flexible catheter; (c) a sampling needle, said sampling needle having a distal tip; and (d) means coupled to said sampling needle for moving said sampling needle between a first position wherein said distal tip of said sampling needle is disposed within said hub and a second position wherein said distal tip of said sampling needle extends distally beyond said distal end of said flexible catheter.
 2. The tissue sampling device as claimed in claim 1 wherein said coupling means comprises a wire, wherein said sampling needle comprises a longitudinal bore and a longitudinally-extending slot, said longitudinally-extending slot permitting access to said longitudinal bore, and wherein said wire is attached to said sampling needle over said longitudinally-extending slot in such a way as to define a gap regulating sample retention within said sampling needle and/or fluid flow between said flexible catheter and said sampling needle.
 3. The tissue sampling device as claimed in claim 1 wherein at least one of said proximal end and said distal end of said hub is outwardly flared.
 4. The tissue sampling device as claimed in claim 1 wherein said distal end of said hub is outwardly flared.
 5. The tissue sampling device as claimed in claim 1 further comprising a seal positioned between said distal end of said hub and said inverted distal end of said flexible catheter.
 6. The tissue sampling device as claimed in claim 1 wherein said sampling needle is shaped to abut the proximal end of said hub in such a way as to form an air-tight seal therewith when said sampling needle is placed in said second position.
 7. The tissue sampling device as claimed in claim 1 further comprising means for coupling a syringe to said flexible catheter so that the syringe and said flexible catheter are in fluid communication.
 8. A method of rendering the tissue sampling device of claim 1 suitable for an additional use, said method comprising the step of reprocessing said tissue sampling device after said tissue sampling device has been used in a patient.
 9. A tissue sampling device, said tissue sampling device comprising: (a) a flexible catheter, said flexible catheter having a proximal end and a distal end; (b) a hub, said hub being substantially tubular and having a proximal end and a distal end, said hub being disposed within said flexible catheter proximate to said distal end thereof; (c) a sampling needle, said sampling needle having a distal tip and a shoulder; and (d) means coupled to said sampling needle for moving said sampling needle between a first position wherein said distal tip of said sampling needle is disposed within said hub and a second position wherein said distal tip of said sampling needle extends distally beyond said distal end of said flexible catheter; (e) wherein said shoulder of said sampling needle is adapted to directly abut said proximal end of said hub to form a seal therewith when said sampling needle is placed in said second position. 